匹卡米隆片剂含量与有关物质测定

目的测定匹卡米隆片剂的含量与有关物质。方法采用紫外分光光度法测定匹卡米隆片的含量,高效液相色谱法测定有关物质。结果紫外分光光度法匹卡米隆在10~60μg.mL-1浓度范围内线性关系量良好(r=0.9999),日内、日间精密度RSD分别为0.32%和1.28%,回收率为99.49%(RSD=0.79%);高效液相色谱法匹卡米隆在10~50μg.mL-1浓度范围内线性关系量良好(r=0.9997),日内、日间精密度RSD分别为0.55%和0.86%,最低检测浓度为25ng.mL-1,杂质与主药分离良好。结论该方法控制匹卡米隆片的含量和有关物质方法可行。

Determination of content and related substances of Picamilon Tablets

OBJECTIVE To establish an UV and HPLC method for determination of content and related substances in Picamilon Tablets.METHODS Determination of content in Picamilon Tablets by UV and determination of related substances in Picamilon Tablets by HPLC.RESULTS The linear range of picamilon measured by UV was 10～60μg·mL-1(r=0.9999),within day and daytime precision RSD was 0.32% and 1.28%,respectively,the recovery rate was 99.49%(RSD=0.79%);The linear range of picamilon measured by HPLC was 10～50μg·mL-1(r=0.9997),the intraday and interday RSD was 0.55% and 0.86%,respectively,with detection limit of 25ng·mL-1,and the impurity and principal agents can be well separated.CONCLUSION This method was available for determination of content and related substances in Picamilon Tablets.